Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

No text entered.

Reporting Groups

Description

Lopinavir/Ritonavir Group

All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Lopinavir/Ritonavir Group

All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.

Baseline Measures

Lopinavir/Ritonavir Group

Overall Participants Analyzed [Units: Participants]

24

Age [Units: Years]Median (Full Range)

30
(21 to 41)

Age [Units: Years]Mean (Standard Deviation)

30 (5.7)

Gender [Units: Participants]

Female

24

Male

0

Region of Enrollment [Units: Participants]

Japan

24

Outcome Measures

1. Primary:

Number of Patients With Adverse Drug Reactions (ADRs) [ Time Frame: During pregnancy and for one year after birth ]

All adverse events that occurred during pregnancy and in their infants for up to one year after birth were reported.

Additional Description

No text entered.

Frequency Threshold

Threshold above which other adverse events are reported

0

Reporting Groups

Description

Lopinavir/Ritonavir Group

All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.

Infants

Infants from live births of the pregnant women who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection who participated in this noninterventional, post-marketing observational study.